{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2014-05651", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141111", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140923", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141112", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "726847", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141111", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20141111", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Unspecified Infection", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20140923", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4243542", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140923", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "12469356", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI CYSTECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS DUE TO A BOWEL RUPTURE. PER THE INFORMATION PROVIDED BY THE SURGEON, IT IS UNKNOWN WHAT CAUSED THE PATIENT'S BOWEL TO RUPTURE." }, { "mdr_text_key": "5051393", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT POST A DA VINCI CYSTECTOMY PROCEDURE, THE PATIENT DEVELOPED AN INFECTION DUE TO A BOWEL LEAK. ON SEPTEMBER 25, 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE PLANNED SURGICAL PROCEDURE, THE SURGEON STATED THAT THE PATIENT UNDERWENT THE DA VINCI CYSTECTOMY PROCEDURE DUE TO BLADDER CANCER AND THAT THREE DAYS POST THE SURGICAL PROCEDURE THE PATIENT COMPLAINED OF ABDOMINAL PAIN. POST-OPERATIVE DAY FIVE THE PATIENT'S PAIN BEGAN TO WORSEN AND A CT SCAN WAS PERFORMED AND SHOWED THAT THE PATIENT HAD FLUID COLLECTION WITH NO EVIDENCE OF AIR. THE SURGEON INDICATED THAT THE HOSPITAL CONTINUED TO MONITOR THE PATIENT AND ON POST-OPERATIVE DAY EIGHT THE PATIENT UNDERWENT A COLONOSCOPY PROCEDURE WHERE IT WAS DISCOVERED THAT THE PATIENT HAD A BOWEL RUPTURE 1.5CM AT THE ILIOCOLIC ANASTOMOSIS AND NECROSIS. ON (B)(6) 2014, THE PATIENT UNDERWENT AN OPEN RESECTION PROCEDURE TO REPAIR THE DEFECT. THE SURGEON INDICATED THAT HE DOES NOT KNOW WHAT CAUSED OR CONTRIBUTED TO THE BOWEL RUPTURE. THE SURGEON INDICATED THAT AS OF (B)(6) 2014 THE PATIENT WAS HOSPITALIZED AND CONTINUED TO EXPERIENCE ILEUS; HOWEVER, THE SURGEON EXPECTED THAT THE PATIENT WOULD BE DISCHARGED FROM THE HOSPITAL IN THE NEXT WEEK. ACCORDING TO THE SURGEON HE USED INTRACORPOREAL TECHNIQUES TO CREATE THE ANASTOMOSIS. HE FIRED 2 BLUE RELOADS FOR THE SIDE TO SIDE ANASTOMOSIS AND 2 BLUE RELOADS TO CREATE THE COMMON OPENING. THE SURGEON INDICATED THAT THE ANASTOMOSED TISSUE WAS HEALTHY AND THE PATIENT HAD NOT UNDERGONE ANY PREVIOUS RADIATION OR CHEMOTHERAPY AND THAT THE PATIENT WAS OTHERWISE HEALTHY AND THAT THE PLANNED SURGICAL PROCEDURE WENT WELL. IT WAS STATED THAT A VISUAL INSPECTION OF ANASTOMOSED TISSUE WAS PERFORMED AND FOUND IT TO BE ADEQUATE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }